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Warning Letter Roundup & Recap – March 13, 2018

 
• By Shawn M. Schmitt

Duodenoscope-makers Olympus, Fujifilm and Pentax Medical failed to conduct post-market surveillance study activities mandated by US FDA in 2015; quality systems violations noted at firms that make dental diagnostic X-ray devices and laser fiber-optic surgical devices. Six device-related warning letters were released by the agency this week.

Warning Rubber Stamp

Check out Medtech Insight's US FDA Warning Letter Data Tracker here.

This chart lists warning letters released by US FDA the week of March 13, 2018. If an inspection led to...

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